MedTrace Logo

Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095) (COMPLETED)

NCT00319995 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1095

Last updated 2024-08-15

No results posted yet for this study

Summary

This is a Phase 3, randomized, parallel-group, multicenter, double-dummy, double-blind study with a screening period. Subjects will receive one of the following three treatment groups for 15 days: loratadine 10 mg/montelukast 10 mg combination, pseudoephedrine 240 mg, or placebo. The primary objective of this study is to assess the efficacy of the combination of loratadine/montelukast, a once-daily tablet containing 10 mg loratadine and 10 mg montelukast, compared with placebo in subjects with seasonal allergic rhinitis (SAR) in relieving the symptom of nasal congestion. The safety profile of combined loratadine/montelukast relative to placebo and pseudoephedrine will also be evaluated.

Conditions

  • Rhinitis, Allergic, Seasonal

Interventions

DRUG

loratadine; montelukast

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-01
Primary Completion
2006-06-01
Completion
2006-06-28

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00319995 on ClinicalTrials.gov